De-Implementing Opioids for Dental Extractions

NCT03584789 | Completed Results DMC

• 2 other identifiers: A17-013U01DE027441
• Study Type: interventional
• Target: 5,722
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this project is to de-implement the reliance on opioid analgesics and to implement reliance on non-opioid analgesics to manage postoperative pain following dental extractions. Using a prospective, provider-level, 3-arm cluster randomized trial design, the investigators will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients.

Conditions

Tooth Extraction

Keywords

Decision Support Systems, Clinical; Pain Management; Analgesics

Outcome Measures

Primary Outcomes (1)

• Opioid Prescribing at the Extraction Encounter

  Number of participants prescribed an opioid.

  At the extraction encounter

Secondary Outcomes (3)

• Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter

  At the extraction encounter

• Compare the Study Arm Differences in Shared Decision-making

  3-6 days after the extraction encounter

• Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain

  3-6 days after the extraction encounter

Study Arms (3)

Standard Practice

NO INTERVENTION

The patients in this arm were part of usual care with their dental provider.

Clinical Decision Support

EXPERIMENTAL

A clinical decision support system designed to assist dentists in providing optimal pain management for patients without resorting to opioids when a non-opioid alternative would suffice. It provides pertinent clinical information to the dentist, including point-of-care access to the Prescription Drug Monitoring Program.

Other: Clinical Decision Support

Clinical Decision Support + Education

EXPERIMENTAL

Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.

Other: Clinical Decision Support; Other: Patient education

Interventions

Clinical Decision Support OTHER

A clinical decision support system designed to assist dentists in providing optimal pain management for patients without resorting to opioids when a non-opioid alternative would suffice. It provides pertinent clinical information to the dentist, including point-of-care access to the Prescription Drug Monitoring Program.

Clinical Decision Support; Clinical Decision Support + Education

Patient education OTHER

Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.

Clinical Decision Support + Education

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a dental extraction of a permanent teeth performed by an eligible HealthPartners provider during the intervention period

You may not qualify if:

• Patients who have opted out of research at HealthPartners
• Meet above age criteria

Sponsors & Collaborators

• HealthPartners Institute: lead
• Friends Research Institute, Inc.: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

HealthPartners Dental Group

Bloomington, Minnesota, 55425, United States

Location

Related Publications (8)

• Rindal DB, Asche SE, Gryczynski J, Kane SM, Truitt AR, Shea TL, Ziegenfuss JY, Schwartz RP, Worley DC, Mitchell SG. De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial. JMIR Res Protoc. 2021 Apr 12;10(4):e24342. doi: 10.2196/24342.

  PMID: 33843594 BACKGROUND

• Mitchell SG, Truitt AR, Davin LM, Rindal DB. Pain management after third molar extractions in adolescents: a qualitative study. BMC Pediatr. 2022 Apr 7;22(1):184. doi: 10.1186/s12887-022-03261-x.

  PMID: 35392856 BACKGROUND

• Rindal DB, Asche SE, Kane S, Truitt AR, Worley DC, Davin LM, Gryczynski J, Mitchell SG. Patient, Provider Type, and Procedure Type Factors Associated with Opioid Prescribing by Dentists in a Health Care System. J Pain Res. 2021 Oct 20;14:3309-3319. doi: 10.2147/JPR.S330598. eCollection 2021.

  PMID: 34707399 BACKGROUND

• Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

  PMID: 23768763 BACKGROUND

• Mitchell SG, Gryczynski J, Worley DC, Asche SE, Truitt AR, Rindal DB. Barriers to dental providers' use of a clinical decision support tool for pain management following tooth extractions. Implement Res Pract. 2025 Feb 9;6:26334895251319810. doi: 10.1177/26334895251319810. eCollection 2025 Jan-Dec.

  PMID: 39931509 DERIVED

• Rindal DB, Pasumarthi DP, Thirumalai V, Truitt AR, Asche SE, Worley DC, Kane SM, Gryczynski J, Mitchell SG. Clinical Decision Support to Reduce Opioid Prescriptions for Dental Extractions using SMART on FHIR: Implementation Report. JMIR Med Inform. 2023 Nov 7;11:e45636. doi: 10.2196/45636.

  PMID: 37934572 DERIVED

• Gryczynski J, Mitchell SG, Asche SE, Truitt AR, Worley DC, Rindal DB. De-Implementing Opioids for Dental Extractions (DIODE): a multi-clinic, cluster-randomized trial of clinical decision support strategies in dentistry. Implement Sci. 2023 Feb 10;18(1):5. doi: 10.1186/s13012-023-01262-7.

  PMID: 36765414 DERIVED

• Rindal DB, Gryczynski J, Asche SE, Truitt AR, Kane SM, Worley DC, Mitchell SG. De-implementing opioid prescribing in a dental group practice: Lessons learned. Community Dent Oral Epidemiol. 2023 Feb;51(1):139-142. doi: 10.1111/cdoe.12820. Epub 2023 Feb 8.

  PMID: 36753410 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: D. Brad Rindal, DDS, Associate Dental Director Research
• Organization: HealthPartners Institute

donald.b.rindal@healthpartners.com

952-967-5026

Study Officials

• D. Brad Rindal, DDS

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Shannon G. Mitchell, PhD

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 12, 2018
• Study Start: February 17, 2020
• Primary Completion: May 14, 2021
• Study Completion: May 21, 2021
• Last Updated: August 30, 2022
• Results First Posted: July 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.
• Access Criteria: Data will be stored at HealthPartners Institute by the project co-principal investigator/site lead and statistician. Study publications will note the method for requesting the study data and technical materials. The study statistician will provide data and accompanying files in an archived zip format to requesters via email. Data will not be stored in a public repository.

Locations

US (1)